HIV InfectionsPhase 3NCT00963235

Safety & Immunogenicity of 13vPnC in HIV-Infected Subjects Aged 18 or Older Who Were Previously Immunized With 23vPS

A Phase 3 study testing 13-valent pneumococcal conjugate vaccine and Blood draw in people with HIV Infections and Pneumococcal Infections, run by Pfizer at 15 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The study will evaluate the safety, tolerability and immunogenicity of a 13-valent pneumococcal conjugate vaccine (13vPnC) in HIV-infected subjects 18 years of age or older who have been previously immunized with at least one dose of 23-valent pneumococcal polysaccharide vaccine (23vPS). Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: HIV Infections, Pneumococcal Infections
What is being tested?: 13-valent pneumococcal conjugate vaccine and Blood draw
Type of treatment: Vaccines, Surgery or procedure
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 331 participants
Where: 15 sitesUnited States
Study dates: Nov 2009to May 2012
Phase: Phase 3
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Male or female subjects aged 18 years or older at the time of enrollment.
All female and male subjects who are biologically capable of having children must agree and commit to the use of a reliable method of birth control from the signing of the informed consent form (ICF) until 3 months after the last dose of investigational product.
Documented vaccination with 1 or more doses of 23vPS at least 6 months before study enrollment.
CD4+ T-cell count >= 200 cells/µ, obtained on the most recent 2 occasions within 6 months before the first investigational product vaccination.
HIV-infected subjects with viral load <50,000 copies/mL, obtained on the most recent 2 occasions within 6 months before the first investigational product vaccination.
Subject is receiving a stable dose of HAART for at least 6 weeks prior to the first investigational product vaccination, or not currently receiving antiretroviral therapy.

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Subject is expected to be available for the entire study period (approximately 18 months) and can be contacted by telephone.
Subject must be able to complete an electronic diary (e-diary) and complete all relevant study procedures during study participation.
Subject is deemed to be eligible for the study on the basis of medical history, physical examination, and clinical judgment. (Note: Subjects with preexisting stable disease, defined as disease not requiring significant change in therapy or hospitalization for worsening disease 6 weeks before investigational product vaccination, are eligible.)

Who cannot join

Subjects with active AIDS related illness, including opportunistic infections or malignancy.
Evidence of current illicit substance and/or alcohol abuse, that in the investigator's opinion, precludes the subject from participating in the study or interferes with the evaluation of the study objectives..
Receipt of any licensed or experimental pneumococcal conjugate vaccine prior to enrollment.
Contraindication to vaccination with pneumococcal conjugate vaccine.
Previous anaphylactic reaction to any vaccine or vaccine-related component.
History of culture-proven invasive disease caused by Streptococcus pneumoniae within the last year.

Show all 22Show fewer

Current anticoagulant therapy or a history of bleeding diathesis or any condition associated with prolonged bleeding time that would contraindicate intramuscular injection. (Note: Use of antiplatelet drugs, such as aspirin and clopidogrel, is permitted.)
Pregnant or breastfeeding women, as defined by history or positive human chorionic gonadotropin (hCG) urine test. All women of childbearing potential must have a urine pregnancy test.
History of active hepatitis with elevation in pretreatment aspartate aminotransferase (AST) or alanine aminotransferase (ALT) values >5 times the upper limit of normal within the last 6 months.
Serious chronic disorder or any other disorder that, in the investigator's opinion, precludes the subject from participating in the study or interferes with the evaluation of the study objectives. (Note: Serious chronic disorders include metastatic malignancy, severe chronic obstructive pulmonary disease requiring supplemental oxygen, end-stage renal disease with or without dialysis, and clinically unstable cardiac disease).
Any major illness/condition that, in the investigator's judgment, will substantially increase the risk associated with the subject's participation in and completion of, the study, or could preclude the evaluation of the subject's response.
History of splenectomy.
Receipt of any blood products, including immunoglobulin, within 42 days before investigational product vaccination until the last blood draw for the study (approximately 13 months after the first investigational product vaccination).
Evidence of dementia or other severe cognitive impairment.
Subject who is, in the opinion of the investigator, unable to receive a vaccination in the deltoid muscle of either arm because of insufficient muscle mass.
Participation in another study using investigational product from 28 days before study enrollment until the blood draw at visit 6. Between the blood draw at visit 6 and the 6 month follow-up telephone call (visit 7), use of investigational product must be discussed with the Medical Monitor. (Note: Participation in purely observational studies is acceptable.)
Residence in a nursing home, long-term care facility, or other institution or requirement of semi-skilled nursing care. An ambulatory resident of a retirement home or village is eligible for the trial.
Subject who is a direct relative (child, grandchild, parent, or grandparent) of study personnel, or who is study personnel.
Temporary Delay Criteria:
Current febrile illness (oral temperature of =38.0°C [100.4°F]) or other acute illness within 48 hours before study vaccine administration.
Currently receiving antibiotic therapy, or has completed a course of antibiotic therapy within 10 days before study vaccine administration.
Receipt of novel influenza A (H1N1) vaccine within 14 days before investigational product vaccination (seasonal influenza vaccine can be given at any time at the discretion of the investigator).

Trial locations and contacts

15 sites in 1 country.

City, postcode or hospital

15 sites in 1 country

United States15 sites

Pfizer Investigational Site
Aurora, Colorado, 80045
Pfizer Investigational Site
Austin, Texas, 78705
Pfizer Investigational Site
Dallas, Texas, 75246
Pfizer Investigational Site
Johnson City, Tennessee, 37604
Pfizer Investigational Site
Lexington, Kentucky, 40536
Pfizer Investigational Site
New York, New York, 10011
Pfizer Investigational Site
New York, New York, 10016
Pfizer Investigational Site
New York, New York, 10029
Pfizer Investigational Site
New York, New York, 10032
Pfizer Investigational Site
New York, New York, 10065
Pfizer Investigational Site
Rochester, New York, 14642
Pfizer Investigational Site
San Francisco, California, 94115
Pfizer Investigational Site
Springfield, Massachusetts, 01199
Pfizer Investigational Site
St Louis, Missouri, 63110
Pfizer Investigational Site
Washington D.C., District of Columbia, 20009

Other trials in United States

About this study

Official title: A Phase 3, Open-label, Single-Arm Trial to Evaluate the Safety, Tolerability, and Immunogenicity of 3 Doses of 13vPnC Vaccine in HIV-Infected Subjects 18 Years of Age or Older Who Have Been Previously Immunized With 23vPS Vaccine

Conditions: HIV Infections, Pneumococcal Infections
Being tested: 13-valent pneumococcal conjugate vaccine, Blood draw
Keywords: vaccine, 13-valent pneumococcal conjugate vaccine, human immunodeficiency virus
Medical subject headings: HIV Infections, Pneumococcal Infections, Acquired Immunodeficiency Syndrome

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

13-valent pneumococcal conjugate vaccineBiological
Also called 13vPnC
Three doses of 13vPnC given 6 months apart.
Blood drawProcedure or surgery
Six blood draws pre-vaccination and 1 month post-vaccination, doses 1-3.

Study groups in NCT00963235
Study group	Role	What they receive
1	Experimental	Not described Receives: Biological: 13-valent pneumococcal conjugate vaccine; Procedure: Blood draw

What is being measured

The primary outcome is the main question the study is designed to answer.

Geometric Mean Fold Rise (GMFR) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody From 1 Month After Dose 2 of 13vPnC to 1 Month After Dose 3 of 13vPnC
Geometric mean fold rises (GMFRs) for the 13 serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) from 1 month post-dose 2 to 1 month post-dose 3 were computed using the logarithmically transformed assay results. Confidence interval (CI) for the GMFRs were back transformations of a CI based on the Student t distribution for the logarithmically transformed assay results.
Measured: 1 month post-dose 2, 1 month post-dose 3

Secondary outcomes (6)

Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After Dose 3 of 13vPnC Relative to 1 Month After Dose 2 of 13vPnC
Antibody GMC for the 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) were presented. GMC (13vPnC) and corresponding 2-sided 95 percent (%) CIs were evaluated. Geometric means (GMs) were calculated using all participants with available data for both post-dose 2 and post-dose 3 blood draws.
Measured: 1 month post-dose 2, 1 month post-dose 3
Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After Dose 2 of 13vPnC Relative to 1 Month After Dose 1 of 13vPnC
Antibody GMC for the 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) were presented. GMC (13vPnC) and corresponding 2-sided 95% CI were evaluated. GMs were calculated using all participants with available data for both post-dose 1 and post-dose 2 blood draws.
Measured: 1 month post-dose 1, 1 month post-dose 2
Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) 1 Month After Dose 3 of 13vPnC Relative to 1 Month After Dose 2 of 13vPnC
Serotype-specific OPA GMTs for the 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) were determined in the blood samples of all the participants using a microcolony OPA (mcOPA) assay. GMT (13vPnC) and corresponding 2-sided 95% CI were evaluated. GMs were calculated using all participants with available data for both post-dose 2 and post-dose 3 blood draws.
Measured: 1 month post-dose 2, 1 month post-dose 3
Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) 1 Month After Dose 2 of 13vPnC Relative to 1 Month After Dose 1 of 13vPnC
Serotype-specific OPA GMTs for the 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) were determined in the blood samples of all the participants using a microcolony OPA (mcOPA) assay. GMT (13vPnC) and corresponding 2-sided 95% CI were evaluated. GMs were calculated using all participants with available data for both post-dose 2 and post-dose 3 blood draws.
Measured: 1 month post-dose 1, 1 month post-dose 2
Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Fold Rise (GMFR) From 1 Month After Dose 2 of 13vPnC to 1 Month After Dose 3 of 13vPnC
GMFRs for the 13 serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) from 1 month post-dose 2 to 1 month post-dose 3 were computed using the logarithmically transformed assay results. CI for the GMFRs were back transformations of a CI based on the Student t distribution for the logarithmically transformed assay results.
Measured: 1 month post-dose 2, 1 month post-dose 3
Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Fold Rise (GMFR) From 1 Month After Dose 1 of 13vPnC to 1 Month After Dose 2 of 13vPnC
GMFRs for the 13 serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) from 1 month post-dose 1 to 1 month post-dose 2 were computed using the logarithmically transformed assay results. CI for the GMFRs were back transformations of a CI based on the Student t distribution for the logarithmically transformed assay results.
Measured: 1 month post-dose 1, 1 month post-dose 2

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Nov 2009May 2012

First posted21 Aug 2009 (estimated)
Study startNov 2009
Primary completionMay 2012
Study completionMay 2012

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for HIV InfectionsStudies of the same condition, open and under way.
More trials run by PfizerThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Prevention
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 331 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00963235
Sponsor's protocol ID: 6115A1-3017
Other IDs: B1851028
Status last verified: Apr 2013
First submitted: 20 Aug 2009
Last updated: 10 Jun 2013
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Publications

Glesby MJ, Watson W, Brinson C, Greenberg RN, Lalezari JP, Skiest D, Sundaraiyer V, Natuk R, Gurtman A, Scott DA, Emini EA, Gruber WC, Schmoele-Thoma B. Immunogenicity and Safety of 13-Valent Pneumococcal Conjugate Vaccine in HIV-Infected Adults Previously Vaccinated With Pneumococcal Polysaccharide Vaccine. J Infect Dis. 2015 Jul 1;212(1):18-27. doi: 10.1093/infdis/jiu631. Epub 2014 Nov 13.
PubMed 25395187

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 10 Jun 2013. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase 3, Open-label, Single-Arm Trial to Evaluate the Safety, Tolerability, and Immunogenicity of 3 Doses of 13vPnC Vaccine in HIV-Infected Subjects 18 Years of Age or Older Who Have Been Previously Immunized With 23vPS Vaccine
ClinicalTrials.gov ID: NCT00963235
Acronym / sponsor ID: 6115A1-3017
Conditions: HIV Infections, Pneumococcal Infections
Keywords: vaccine, 13-valent pneumococcal conjugate vaccine, human immunodeficiency virus
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 331 participants (actual)
Lead sponsor: PfizerIndustry (pharma, biotech, devices)
Study start: Nov 2009
Primary completion: May 2012 (actual)
Study completion: May 2012 (actual)
First posted: 21 Aug 2009 (estimated)
Results: Posted 10 Jun 2013

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Prevention
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
1	Experimental	Biological: 13-valent pneumococcal conjugate vaccine, Procedure: Blood draw

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (9 listed)

Male or female subjects aged 18 years or older at the time of enrollment.
All female and male subjects who are biologically capable of having children must agree and commit to the use of a reliable method of birth control from the signing of the informed consent form (ICF) until 3 months after the last dose of investigational product.
Documented vaccination with 1 or more doses of 23vPS at least 6 months before study enrollment.
CD4+ T-cell count >= 200 cells/µ, obtained on the most recent 2 occasions within 6 months before the first investigational product vaccination.
HIV-infected subjects with viral load <50,000 copies/mL, obtained on the most recent 2 occasions within 6 months before the first investigational product vaccination.

Key exclusion criteria (22 listed)

Subjects with active AIDS related illness, including opportunistic infections or malignancy.
Evidence of current illicit substance and/or alcohol abuse, that in the investigator's opinion, precludes the subject from participating in the study or interferes with the evaluation of the study objectives..
Receipt of any licensed or experimental pneumococcal conjugate vaccine prior to enrollment.
Contraindication to vaccination with pneumococcal conjugate vaccine.
Previous anaphylactic reaction to any vaccine or vaccine-related component.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
13-valent pneumococcal conjugate vaccineAlso: 13vPnCThree doses of 13vPnC given 6 months apart.	Biological	1
Blood drawSix blood draws pre-vaccination and 1 month post-vaccination, doses 1-3.	Procedure or surgery	1

Primary outcome

Geometric Mean Fold Rise (GMFR) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody From 1 Month After Dose 2 of 13vPnC to 1 Month After Dose 3 of 13vPnC
Time frame: 1 month post-dose 2, 1 month post-dose 3
Geometric mean fold rises (GMFRs) for the 13 serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) from 1 month post-dose 2 to 1 month post-dose 3 were computed using the logarithmically transformed assay results. Confidence interval (CI) for the GMFRs were back transformations of a CI based on the Student t distribution for the logarithmically transformed assay results.

6 secondary outcomes

Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After Dose 3 of 13vPnC Relative to 1 Month After Dose 2 of 13vPnC
Time frame: 1 month post-dose 2, 1 month post-dose 3
Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After Dose 2 of 13vPnC Relative to 1 Month After Dose 1 of 13vPnC
Time frame: 1 month post-dose 1, 1 month post-dose 2
Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) 1 Month After Dose 3 of 13vPnC Relative to 1 Month After Dose 2 of 13vPnC
Time frame: 1 month post-dose 2, 1 month post-dose 3
Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) 1 Month After Dose 2 of 13vPnC Relative to 1 Month After Dose 1 of 13vPnC
Time frame: 1 month post-dose 1, 1 month post-dose 2
Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Fold Rise (GMFR) From 1 Month After Dose 2 of 13vPnC to 1 Month After Dose 3 of 13vPnC
Time frame: 1 month post-dose 2, 1 month post-dose 3
Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Fold Rise (GMFR) From 1 Month After Dose 1 of 13vPnC to 1 Month After Dose 2 of 13vPnC
Time frame: 1 month post-dose 1, 1 month post-dose 2

Results and safety

Results posted to the registry on 10 Jun 2013, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
13vPnC	331	271

Primary outcome: Geometric Mean Fold Rise (GMFR) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody From 1 Month After Dose 2 of 13vPnC to 1 Month After Dose 3 of 13vPnC

Time frame: 1 month post-dose 2, 1 month post-dose 3. Geometric mean (95% Confidence Interval). Unit: fold rise

Measure	13vPnC n = 223
Serotype 1	0.94 (0.88 to 1.01)
Serotype 3	1.01 (0.95 to 1.08)
Serotype 4	1.01 (0.94 to 1.08)
Serotype 5	0.99 (0.94 to 1.05)
Serotype 6A	1.19 (1.11 to 1.27)
Serotype 6B	1.21 (1.13 to 1.31)
Serotype 7F	1.07 (1.00 to 1.14)
Serotype 9V	1.08 (1.02 to 1.15)

Population analysed: Evaluable immunogenicity population: eligible participants who were \>=18 years of age on the day of first vaccination, received at least 2 doses of 13vPnC in the sequence assigned, had valid and determinate assay results, and had no major protocol violations. N (number of participants analyzed)=participants who were evaluable for this measure.

6 secondary outcomes are reported in the full results.

Adverse events

Time frame: Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose). Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
13vPnC (After Dose 1 and Before Dose 2)	24 of 329 (7.3%)	244 of 329 (74.2%)	Not reported
13vPnC (After Dose 2 and Before Dose 3)	14 of 300 (4.7%)	196 of 300 (65.3%)	Not reported
13vPnC (After Dose 3 and Before Dose 3 Blood Draw)	4 of 278 (1.4%)	169 of 278 (60.8%)	Not reported
13vPnC (After Dose 3 Blood Draw)	10 of 329 (3%)	30 of 329 (9.1%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 10 Jun 2013.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 25395187Glesby MJ, Watson W, Brinson C, Greenberg RN, Lalezari JP, Skiest D, Sundaraiyer V, Natuk R, Gurtman A, Scott DA, Emini EA, Gruber WC, Schmoele-Thoma B. Immunogenicity and Safety of 13-Valent Pneumococcal Conjugate Vaccine in HIV-Infected Adults Previously Vaccinated With Pneumococcal Polysaccharide Vaccine. J Infect Dis. 2015 Jul 1;212(1):18-27. doi: 10.1093/infdis/jiu631. Epub 2014 Nov 13.
To obtain contact information for a study center near you, click here.Link provided by the sponsor.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Pfizer CT.gov Call Center study director

Pfizer

15 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing 13-valent pneumococcal conjugate vaccine and Blood draw in people with HIV Infections and Pneumococcal Infections, run by Pfizer at 15 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 10 Jun 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 15 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 10 Jun 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Geometric Mean Fold Rise (GMFR) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody From 1 Month After Dose 2 of 13vPnC to 1 Month After Dose 3 of 13vPnC (time frame: 1 month post-dose 2, 1 month post-dose 3). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00963235, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jun 2013.